First OTC Acetaminophen-Naproxen Combo Approved

The FDA approved acetaminophen 325mg/naproxen sodium 110mg (Tylenol with Naproxen, Kenvue), the first nonprescription fixed-dose product to combine the two pain relievers in a single tablet. The over-the-counter (OTC) product provides pain relief for up to 12 hours.

Tylenol with Naproxen is indicated for the temporary relief of minor aches and pains associated with headache, backache, muscular aches, toothache, menstrual cramps, and minor arthritis pain. The product is approved for adults and children aged 12 years and older.

According to the FDA, the approval was supported by evidence establishing the combination’s safety and effectiveness and demonstrating the contribution of each active ingredient to its overall pain-relieving effect. Tylenol with Naproxen is dosed every 12 hours, and its labeling includes standard warnings applicable to both acetaminophen- and nonsteroidal anti-inflammatory drug (NSAID)-containing products.

The FDA warns consumers not to use Tylenol with Naproxen with other acetaminophen-containing products because doing so may cause liver damage. The labeling also includes warnings about stomach bleeding and increased risks of heart attack, heart failure, and stroke. The agency noted that the NSAID-related risks are greater when these products are used in larger amounts or for longer than directed.People who are pregnant or breastfeeding are advised to consult a healthcare professional before using the product. 

For healthcare professionals , the new combination may be relevant during medication reconciliation and counseling about duplicate acetaminophen use, NSAID-related warnings, and adherence to the product labeling.

Source: FDA. FDA approves first nonprescription fixed-dose combination of acetaminophen and naproxen sodium for 12-hour pain relief. News release. FDA; July 24, 2026. Accessed July 25, 2026.